DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/11/2026 has been entered.
Response to Arguments
Applicant’s arguments filed 04/27/2026 have been fully considered but are not persuasive or are moot in view of a new grounds of rejection.
Applicant argues, “As amended, claim 1 requires (a) obtaining measurements from a pair of body-mounted sensors positioned on opposite sides of a joint; (b) computing a relative angle between sensors and a joint angle defined in a plane of normal bending; and (c) omitting joint angles/relative angles from stored or reported joint information when unworn is detected. These steps are rooted in physical sensor measurements and device operation, and are not practically performable "in the human mind" as the examiner suggests.”
Examiner respectfully states that the above recited limitations are directed to additional elements.
Specifically, the above recited additional elements are insignificant extra solution activities. Specifically, using a pair of sensors to obtain measurements relating to the first and second body part is directed towards pre-solution activity since it collects measurements that will later be analyzed and calculated (i.e. mathematical calculations and outputs) relating to the joint angle and the relative angle.
Additionally, the limitations, “in response to determining that the sensor system is in the unworn state, omitting, from stored or reported joint information, any joint angle or relative angle calculated using measurements obtained after the determination that the sensor system is in the unworn state”, are directed to insignificant post solution activity (see MPEP 2106.05(g)).
7. The above recited limitations merely process information and then omit information. There is nothing in the claims which show how omitting information integrates the judicial exception into a practical application.
9. Further, Examiner asserts that the limitations are not particular and instead provide instructions to apply the exception in a generic way (see factor ‘a’ in MPEP §2106.04(d)(2)). There is nothing in the claim which shows how omitting information integrates the abstract idea into a practical application.
10. Moreover, there is no evidence of record that would support the assertion that this step is an improvement to a computer or a technological solution to a technological problem.
Applicant argues, “Claim 1 now expressly requires: "in response to determining that the sensor system is in the unworn state, omitting, from stored or reported joint information, any joint angle or relative angle calculated using measurements obtained after the determination that the sensor system is in the unworn state." This limitation is not "post-solution activity." It is an operational control step that changes how the device (or associated system) stores or reports joint information to prevent inclusion of data that would misrepresent the user's joint motion. The specification explains that a key technical problem in wearable joint monitoring is that when sensors are removed, dislodged, or otherwise unworn, measurements become misleading and can skew joint monitoring information.”
Examiner respectfully disagrees. As stated above, the recited limitations merely process information and then omit information. There is nothing in the claims which show how omitting information integrates the judicial exception into a practical application.
Accordingly, claims 1-2 and 4-18 are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas.
Applicant argues, “The amended claim requires a concrete action that changes system behavior: it prevents storage or reporting of joint angle/relative angle values computed after unworn detection. This is not an abstract "label" or a purely informational output; it is a functional constraint on the system's data pipeline, improving the integrity of stored/reported joint information. The specification expressly discusses that including measurements taken when the sensors are removed/dislodged can mislead monitoring and "skew" the joint information, and that the system therefore omits or otherwise avoids using such data after detecting unworn. IV. The claim is tied to a particular technological context and improves it…. These limitations collectively describe a specific wearable joint-monitoring technique that improves the operation of the monitoring system by preventing corrupted or unrepresentative data from entering the system's stored/reported outputs. This is "significantly more" than a mathematical relationship or mental process in the abstract.”
Examiner respectfully disagrees. Although the amended claim prevents storage or reporting agter unworn detection, the recited “omitting, from stored or reported joint information, any joint angle or relative angle calculated using measurements obtained after the determination that the sensor system is in the unworn state”, is still directed to insignificant post solution activity (see MPEP 2106.05(g)), as discussed above.
Additionally, regarding the limitations:
“a sensor system comprising a pair of sensors configured for mounting on first and second body parts,
each sensor containing one or more motion sensing devices,
a calculation unit,”
see Lucas et al. (US 2015/0022362), which discloses a wearable device (fig. 1: 100) that detects improper movements at a body joint [0001], and teaches
a sensor system (fig. 2: 110) comprising a pair of sensors (120a, 120n; [0052]) configured for mounting on first and second body parts ([0052]: sensors provide information regarding position of first bone 10 and second bone 30),
each sensor containing one or more motion sensing devices ([0005]: device senses relative motion; [0011]: detects position based on movement of a body part; [0052]),
a calculation unit ([0043-0045]: detecting improper movement of a body joint).
Thus, the limitations directed to a sensor system comprising a pair of sensors configured for mounting on first and second body parts, each sensor containing one or more motion sensing devices, and a calculation unit are well-understood, routine, and conventional, as evidenced by the reference above.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
In re claim 18: “a calculation unit.”
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2 and 4-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea without significantly more.
Step 1:
Independent claims 1 and 18 recite a method for determining an unworn state of a sensor system recordings and a system for providing information about a joint. Thus, they are directed to statutory categories of invention.
Step 2A, Prong 1:
Claims 1 and 18 recite the following claim limitations which are directed to mathematical concepts (see MPEP § 2106.04(a)(2), subsection I):
Claim 1:
“calculating a relative angle between the pair of sensors using one or more of the one or more measurements” (mathematical relationships, mathematical formulas or equations, and mathematical calculations)
“calculating, using one or more of the one or more measurements, a joint angle between the first and second body parts” (mathematical relationships, mathematical formulas or equations, and mathematical calculations)
In re claim 18, see in re claim 1 above.
These limitations, under their broadest reasonable interpretation, cover mathematical concepts. For instance, the relative angle and joint angle are calculated using measurements, which further implies that they are mathematical concepts, specifically mathematical calculations based on mathematical relationships and formulas. Therefore, since the claim limitations can be broken down into mathematical relationships, formulas or equations, and calculations, the claim limitations fall within the ‘mathematical concepts’ grouping of abstract ideas.
Additionally, claims 1-20 recite limitations directed toward a mental process.
Claim 1 recites: “determining based on the calculated angles, whether either or both of the sensors is not mounted and if so, determining that the sensor system is in the unworn state.”
This limitation is directed towards judgment and evaluation, and can be done in the human mind by a doctor determining whether or not sensors are mounted on the patient’s joint, and if they are not mounted, then determining that the sensor system in in the unworn state.
In re claim 18, see in re claim 1 above.
Therefore, each of the above identified claims recite an abstract idea.
Step 2A, Prong 2:
Claims 1 and 18 recite the following additional elements:
Claim 1:
“… a sensor system comprising a pair of sensors configured for mounting on first and second body parts either side of a joint,”
“with each sensor containing one or more motion sensing devices which permit either
{iI a pitch and/or roll of the individual sensor to be determined or
{iiI the relative pitch and/or roll between the sensors to be determined”,
“obtaining one or more measurements from each sensor,”
“where the joint angle is defined in a plane of normal bending of the joint,” and
“in response to determining that the sensor system is in the unworn state, omitting, from stored or reported joint information, any joint angle or relative angle calculated using measurements obtained after the determination that the sensor system is in the unworn state.”
Claim 18:
“A first sensor unit configured to be mounted on a first body part on a first side of the joint,
the first sensor unit comprising:
one or more first sensors arranged to take one or more measurements relating to
the first body part and
one or more measurements relating to the one or more first sensors; and
a transmitter arranged to transmit taken measurements; and
a second master sensor unit configured to be mounted on a second body part on a second side of the joint,
the second master sensor unit comprising: one or more second sensors arranged to take
one or more measurements relating to the second body part and
one or more measurements relating to the one or more second sensors;
with each sensor containing one or more motion sensing devices which permit either
{iI a pitch and/or roll of the individual sensor to be determined or
{iiI the relative pitch and/or roll between the sensors to be determined,
a receiver arranged to receive the one or more measurements relating to
the first body part and
the one or more measurements relating to the one or more first sensors transmitted from the transmitter of the first sensor unit; and
a calculation unit
where the joint angle is defined in a plane of normal bending of the joint;
wherein the calculation unit is further configured to, in response to determining that the sensor system is in the unworn state, omit, from stored or reported joint information, any joint angle or relative angle calculated using measurements obtained after the determination that the system is in the unworn state.”
The limitations above refer to using mathematical concepts to calculate a relative angle and a joint angle so that a determination can be made on whether or not the pair of sensors are mounted, and if so, then determining that the sensor system is in an unworn state. This step is post-solution activity since it provides a determination of whether or not the sensor system is in an unworn state based off of the relative angle and the joint angle.
Additionally, the above recited additional elements are insignificant extra solution activities. Specifically, using a pair of sensors to obtain measurements relating to the first and second body part is directed towards pre-solution activity since it collects measurements that will later be analyzed and calculated (i.e. mathematical calculations and outputs) relating to the joint angle and the relative angle.
Therefore, determine that the system is in an unworn state is merely data gathering in conjunction with mathematical concepts and the additional elements do not integrate a judicial exception into a practical application. Thus, the abstract idea is not integrated into a practical application. The combination of these additional elements is no more than insignificant extra solution activity, and mere data gathering, mathematical calculations, and mathematical functions. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
Additionally, the limitations, “in response to determining that the sensor system is in the unworn state, omitting, from stored or reported joint information, any joint angle or relative angle calculated using measurements obtained after the determination that the sensor system is in the unworn state”, are directed to insignificant post solution activity (see MPEP 2106.05(g)).
7. The above recited limitations merely process information and then omit information.
8. There is nothing in the claims which show how omitting information integrates the judicial exception into a practical application.
9. Further, Examiner asserts that the limitations are not particular and instead provide instructions to apply the exception in a generic way (see factor ‘a’ in MPEP §2106.04(d)(2)). There is nothing in the claim which shows how omitting information integrates the abstract idea into a practical application.
10. Moreover, there is no evidence of record that would support the assertion that this step is an improvement to a computer or a technological solution to a technological problem.
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Additionally, regarding the limitations:
“a sensor system comprising a pair of sensors configured for mounting on first and second body parts,
each sensor containing one or more motion sensing devices,
a calculation unit,”
see Lucas et al. (US 2015/0022362), which discloses a wearable device (fig. 1: 100) that detects improper movements at a body joint [0001], and teaches
a sensor system (fig. 2: 110) comprising a pair of sensors (120a, 120n; [0052]) configured for mounting on first and second body parts ([0052]: sensors provide information regarding position of first bone 10 and second bone 30),
each sensor containing one or more motion sensing devices ([0005]: device senses relative motion; [0011]: detects position based on movement of a body part; [0052]),
a calculation unit ([0043-0045]: detecting improper movement of a body joint).
Thus, the limitations directed to a sensor system comprising a pair of sensors configured for mounting on first and second body parts, each sensor containing one or more motion sensing devices, and a calculation unit are well-understood, routine, and conventional, as evidenced by the reference above.
As discussed with respect to Step 2A Prong Two, the additional elements in the claims amount to no more than insignificant extra solution activity and mere data gathering combined with mathematical concepts. The same analysis applies here in 2B and does not provide an inventive concept.
Therefore, none of the claims 1-2 and 4-18 amounts to significantly more than the abstract idea itself. Accordingly, claims 1-2 and 4-18 are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas which use mathematical concepts and mere data gathering as further discussed in the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al., MPEP 2106.04(a)(2), and MPEP 2106.05(g).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1-2, 4-8, 10 and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Leavitt et al. (US 2019/0038225) in view of Lucas et al. (US 2015/0022362) in view of Wang et al. (US 2021/0298612).
In re claim 1, Leavitt discloses
a method for determining an unworn state of a sensor system [0094-0095] comprising a pair of sensors (fig. 9A: inertial sensors 970 and 972; [0147]) configured for mounting on first ([0147]: sensor 970 corresponds to first body portion) and second body parts ([0147]: sensor 972 corresponds to second body portion) either side of a joint (fig. 9A: 970 and 972 on either side of joint 950; [0147]),
with each sensor containing one or more motion sensing devices ([0147]: sensors comprise an inertial sensor) which permit either
{iI a pitch and/or roll (fig. 9B) of the individual sensor to be determined (fig. 9B: pitch of the sensor is determined relative to the vertical reference 980, for instance angle 982 for the inertial sensor 972 and angle 981 for the inertial sensor 970; [0147-0148]) or
{iiI the relative pitch and/or roll (fig. 9B) between the sensors to be determined (fig. 9B: relative pitch between the sensors i.e. angle 983 is determined; [0147-0148]),
the method comprising:
obtaining one or more measurements from each sensor ([0096]: inertial data is used to sample “motion and/or position or orientation data” which is referred to as spatial rehabilitation data; [0094, 0147-0148]);
calculating a relative angle between the pair of sensors using one or more of the one or more measurements (fig. 9B: relative angle is joint flexion angle 983 which is calculated by subtracting 981 from 982; [0148]);
calculating, using one or more of the one or more measurements, a joint angle between the first and second body parts ([0099]: static angle resolution is determined from the spatial rehabilitation data which corresponds to joint angle),
where the joint angle is defined in a plane of normal bending of the joint ([0099]: static angle resolution provides a range of motion detection i.e. bending of the joint which would be in a plane of normal bending; [0148]): and
determining based on at least one of the calculated relative angle and the calculated joint angle whether either or both of the sensors is not mounted ([0094-0096]: relative orientations and/or prolonged absence of motion corresponds to the wearable joint rehabilitation device not being worn and orientations would include the calculated relative angle and the calculated joint angle) and
if so, determining that the sensor system is in the unworn state [0094].
Leavitt fails to disclose
determining, based on the calculated angles, whether either or both of the sensors is not mounted and if so, determining that the sensor-system is in the unworn state; and
in response to determining that the sensor system is in the unworn state, omitting, from stored or reported joint information, any joint angle or relative angle calculated using measurements obtained after the determination that the sensor system is in the unworn state.
Regarding the limitation, “determining, based on the calculated angles, whether either or both of the sensors is not mounted and if so, determining that the sensor-system is in the unworn state,”
Lucas teaches a wearable device (fig. 1: 100) that detects improper movements at a body joint [0001]
which monitors
a joint angle ([0043]: joint angle is bend angle formed on a transverse axis by first bone 30 relative to second bone 10; fig. 1) and
a relative angle ([0043]: relative angle is formed on a lateral axis by a horizontal displacement of the first bone 30 relative to the second bone 10; fig. 1), and
determines, based on the calculated angles [0045] whether there is an improver movement at a body joint ([0009, 0045]: combination of the bend and inward lateral angle is used to detect improper movement).
Lucas further teaches that a signal can be generated to indicate that the knee has made an improper movement [0009, 0025], and allows for feedback to be generated [0025] based on a combination of the angles [0009, 0045].
The proposed combination would yield wherein a combination of the joint angle and relative angle of Leavitt is used to determine whether either or both of the sensors is not mounted and if so, determining that the sensor-system is in the unworn state, similar to how a combination of the joint angle and relative angle of Lucas is used to detect improper movement of a body joint, because both the joint angle and the relative angle of Leavitt provide information corresponding to the bending of the joint.
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for determining an unworn state of a sensor system taught by Leavitt, to provide determining, based on the calculated angles, whether either or both of the sensors is not mounted and if so, determining that the sensor-system is in the unworn state, as taught by the joint and relative angle of Lucas being used to detect improper movement of a body joint, because doing so allows for feedback to be generated based on a combination of the angles.
Regarding the limitations, “in response to determining that the sensor system is in the unworn state, omitting, from stored or reported joint information, any joint angle or relative angle calculated using measurements obtained after the determination that the sensor system is in the unworn state”,
Wang teaches an arm belt [0035] and an arm belt position detection device [0035] for detecting a position of the arm belt [0085], wherein in response to determining that the arm belt is improperly worn [0088], omitting, from stored information, any pressure value obtained after the determination that the arm belt is improperly worn ([0088]: pressure value is deleted after detecting that a user is improperly wearing the arm belt, which means the pressure value must have been stored at one point).
Wang further teaches that system errors ([0087-0088]: wear position is wrong or accurate information cannot be detected) ensure that collected data is not saved [0088] and provides a prompt to the user that something is wrong with the arm belt [0088].
The proposed combination would yield “in response to determining that the sensor system is in the unworn state, omitting, from stored or reported joint information, any joint angle or relative angle calculated using measurements obtained after the determination that the sensor system is in the unworn state” , similar to how pressure value information is deleted in Wang when the arm belt is improperly worn, because doing so prevents unwanted information from being saved when a system error is detect.
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for determining an unworn state of a sensor system yielded by the proposed combination, to provide in response to determining that the sensor system is in the unworn state, omitting, from stored or reported joint information, any joint angle or relative angle calculated using measurements obtained after the determination that the sensor system is in the unworn state, as taught by the pressure information of Wang being deleted upon detecting the arm belt being improperly worn, because detecting system errors ensure that collected data is deleted accordingly and provides a prompt to the user that something is wrong with the sensor system.
In re claim 2, Leavitt discloses
wherein obtaining the one or more measurements from each of the pair of sensors is performed multiple times in a time period [0104-0106] and
the calculating the relative angle and the calculating the joint angle is performed using measurements obtained at least some of the multiple times (fig. 6: on-body-joint sensing 640 occurs multiple time due to the arrow which exits 640 and goes back to block 635; [0094]: adaptive delay sample rate control can be adjusted i.e. measurements are obtained multiple times),
the method comprising the further step of, following the determination that the sensor system is in the unworn state (see in re claim 1 above), adopting a different procedure with regard to calculating the joint angle at subsequent times ([0094]: adaptive delay sample rate set to a low-rate resting mode with longer periods between samples).
In re claim 4, Leavitt discloses further comprising
correlating the joint angles and the relative angles calculated at multiple times to provide information about the joint over the time period ([0094]: relative orientations and detecting a prolonged absence of motion corresponds to information about the joint over a period of time; [0135-0140]: device can measure information about the joint over a period of time such as motion and improvement in daily activity), and
wherein adopting the different procedure comprises omitting, from the stored or reported information, any data calculated using measurements obtained after determining that the sensor system is in the unworn state (see the proposed combination yielded in re claim 1 above, where stored data is omitted after detecting an unworn state; see also Leavitt: [0094]: adaptive delay sample rate may be set to a low-rate resting mode which means omitting data made at subsequent times compared to if the adaptive delay sample rate was not in low-rate resting mode).
In re claim 5, Leavitt discloses wherein the information comprises any one or more of:
joint angle variation during the time period ([0094]: relative orientation provides information about joint angle variation depending on the adaptive delay sample rate control);
a duration of time in which the joint is active [0136, 0138];
a duration of time in which the joint is bearing a load;
a length of the time period; and
if the joint is a knee, a step count over the time period.
In re claim 6, Leavitt discloses
wherein adopting the different procedure comprises performing calculations to provide different information from the information about the joint ([0094]: adopting a different procedure i.e. a low-rate resting mode is based on calculations to determine a prolonged absence of motion and/or relative orientations detected),
wherein the different information includes any one or more of:
an unworn time ([0094]: prolonged absence of motion is detected); and
if the one of the pair of sensors is determined to be charging, a charging time.
In re claim 7, Leavitt discloses
wherein the pair of sensors includes a first sensor and a second sensor (see in re claim 1 above),
wherein the unworn state includes any one or more of:
the first sensor having been at least partially removed from its mounted position ([0094]: if the wearable joint rehabilitation device is not being worn at all then the first sensor will be at least partially removed from its mounted position);
the first sensor falling off its mounted position at least to some extent;
the first sensor being switched on but not mounted on the first body part; and
the second sensor being switched on but not mounted on the second body part.
In re claim 8, Leavitt discloses wherein determining whether either or both of the pair of sensors are mounted on the first or second body parts based on a value of a function of at least one of the calculated relative angle and the calculated joint angle ([0094-0096]: spatial rehabilitation data i.e. calculated joint angle and calculated relative angle from the sensor data which provides position information is used to determine if the wearable harness is worn; [0136]: sensor data provides data on motion; [0029, 0099]; [0094-0095]: relative orientations and/or prolonged absence of motion used to determine if both of the sensors are being worn).
In re claim 10, Leavitt fails to disclose wherein the function comprises a function of
a joint angle penalty and
a relative angle penalty.
Lucas teaches wherein a function ([0043]: threshold comprises the bend angle and the lateral angle) comprises a function of
a joint angle penalty ([0060]: whether the first bend angle exceeds a threshold; [0022-0023]) and
a relative angle penalty ([0060]: whether the first lateral angle exceeds a threshold; [0022-0023]).
Lucas further teaches that a signal can be generated to indicate that the knee has made an improper movement depending on the threshold being exceeded [0025], and allows for feedback to be generated [0025].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for determining an unworn state of a sensor system yielded by the proposed combination, to provide wherein the function comprises a function of a joint angle penalty and a relative angle penalty, as taught by Lucas, because doing so provides an indication for improper movement of a joint and then generates feedback.
In re claim 15, Leavitt discloses further comprising
wherein the pair of sensors includes a first sensor and a second sensor (see in re claim 1 above),
the method further comprising,
prior to the obtaining, determining whether the first sensor and the second sensor are mounted
on correct respective first and second body parts and/or
in substantially a predetermined orientation relative to the correct respective first and second body parts ([0093]: healthcare provider may instruct a patient to position the joint in selected positions or orientation while the wearable joint rehabilitation device is mounted on the first and second body parts), and
if one or both sensors is determined to be mounted on a wrong body part or in a different orientation from the predetermined orientation ([0094]: detection that there is a prolonged absence of motion that corresponds to the wearable joint rehabilitation device not being worn i.e. the sensors are in a different orientation from the predetermined orientation, such as from the are not being worn), adjusting the calculating steps to take account of an actual determined mounting
location and/or
orientation ([0094]: upon detecting prolonged absence of motion, it’s determined that the mounting orientation is of the wearable joint rehabilitation device not being worn, which adjusts the delay sample rate between sample acquisitions).
In re claim 16, Leavitt discloses wherein the pair of sensors includes a first sensor and a second sensor, the method further comprising, prior to the obtaining (fig. 6: prior to 640), calibrating the first sensor and the second sensor (630; [0093]) with respect to a predetermined orientation relative to the respective first and second body parts [0093].
In re claim 17, Leavitt discloses wherein the joint is a knee (fig. 2A) or an elbow (fig. 2B).
In re claim 18, Leavitt discloses a system for providing information about a joint (fig. 2A: 250; inertial sensors 970 and 972 shown in fig. 9A can be used in the wearable harness show in in fig. 2A [0014, 0025]; [0094-0095]), comprising:
a first sensor unit (fig. 2A: smart buckle 265; [0062]) configured to be mounted on a first body part (fig. 2A: smart buckle 265 located on upper leg) on a first side of the joint (fig. 2A),
the first sensor unit comprising:
one or more first sensors (fig. 4: 405; [0072]: integrated components within a smart buckle) arranged to take one or more measurements relating to
the first body part ([0096]: inertial data is used to sample “motion and/or position or orientation data” which is referred to as spatial rehabilitation data; [0094, 0147-0148]) and
one or more measurements relating to the one or more first sensors [0075-0076]; and
a transmitter arranged to transmit taken measurements (fig. 4: 420); and
a second master sensor unit (254) configured to be mounted on a second body part (fig. 2A: smart buckle 254 located on lower leg) on a second side of the joint (fig. 2A),
the second master sensor unit comprising:
one or more second sensors (fig. 4A: 446; [0076]: second inertial sensor) arranged to take one or more measurements relating to
the second body part [0075-0076, 0094] and
one or more measurements relating to the one or more second sensors [0075-0076];
with each sensor containing one or more motion sensing devices (see in re claim 1 above) which permit either
{i} a pitch and/or roll of the individual sensor to be determined (see in re claim 1 above) or
{ii} the relative pitch and/or roll between the sensors to be determined (see in re claim 1 above),
a receiver ([0076]: part of processor 425 which receives information on first and second inertial sensor data) arranged to receive the one or more measurements relating to
the first body part [0076-0077] and
the one or more measurements relating to the one or more first sensors transmitted from the transmitter of the first sensor unit [0076-0077]; and
a calculation unit ([0097]: part of on-device data processing which processes spatial rehabilitation data; [0076]: processor 425) configured to calculate, using one or more of the measurements [0075-0077, 0148],
a relative angle between the first sensor unit and the second master sensor unit (see in re claim 1 above) and
a joint angle between the first and second body parts (see in re claim 1 above),
where the joint angle is defined in a plane of normal bending of the joint (see in re claim 1 above).
Regarding the limitations,
“the calculation unit being further configured to determine, based on the calculated relative angle and the calculated joint angle, whether either or both of the first sensor unit and the second master sensor unit are not mounted and if so, determine that the system is in an unworn state; and
wherein the calculation unit is further configured to, in response to determining that the sensor system is in the unworn state, omit, from stored or reported joint information, any joint angle or relative angle calculated using measurements obtained after the determination that the system is in the unworn state”,
see the proposed combination yielded in re claim 1 above.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Leavitt et al. (US 2019/0038225) in view of Lucas et al. (US 2015/0022362) in view of Wang et al. (US 2021/0298612) in view of Galiana Bujanda et al. (US 2021/0007874).
In re claim 9, Leavitt discloses further comprising
processing multiple calculated values of the function over a time period to determine a range-of-motion value for the function ([0099]: max and min joint angles reached within a period of time are used to calculate a range-of-motion; [0101, 0105]) and
wherein the determining further comprises comparing the determined range-of-motion value to a threshold value ([0133]: range of motion is compared with a threshold value i.e. expected progress and provides an indication of there are deviations).
Leavitt fails to disclose further comprising
processing multiple calculated values of the function over a time period to determine a moving average value for the function and
wherein the determining further comprises comparing the determined moving average value to a threshold value.
Galiana Bujanda teaches an wearable device [0007] that actuates movement about a joint of a wearer [0007], and teaches
processing multiple calculated values of a function over a time period ([0473]: joint angles of a hip are measured over time to calculate an average angle to determine if the hip is moving up or down based on a change in the average angle; [0431]) to determine a moving average value for the function ([0473]: moving average is the change in the average angle of the hip joints; [0431]) and
wherein a determining of a transition to a moving up state or a moving down state [0473] further comprises comparing the determined moving average value to a threshold value ([0431]: threshold used to indicate the start of the lifting motion or crouching pose to be assisted; [0473]).
Galiana Bujanda further teaches that the average angle of the hip joints changing about seven degrees from a neutral angle of the joints can indicate a change in movement [0473, 0536].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for determining an unworn state of a sensor system taught by Leavitt, to provide processing multiple calculated values of the function over a time period to determine a moving average value for the function and wherein the determining further comprises comparing the determined moving average value to a threshold value, as taught by Galiana Bujanda, because comparing the change in average joint angle with a threshold allows for the detection of movement in the joint angle, which will allow Leavitt to further detect if the wearable device is being worn.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Leavitt et al. (US 2019/0038225) in view of Lucas et al. (US 2015/0022362) in view of Wang et al. (US 2021/0298612) in view of Kang (US 2019/0066832).
In re claim 11, the proposed combination fails to yield wherein
if the joint angle is within a feasible range for the joint, the joint angle penalty is zero and
if the joint angle is not within the feasible range for the joint, the joint angle penalty has a value which depends on how far outside the feasible range the joint angle is.
Kang teaches a method for detecting patient risk during physical therapy [0008], and teaches wherein
if a joint angle ([0086]: joint angle is measured range of motion in a degree of freedom in a joint of interest) is within a feasible range for a joint ([0086]: if the measured range of motion is within a target range of motion), a joint angle penalty is zero ([0086-0087]: risk score is the magnitude of differences between the actual ranges of motion and the target ranges of motion in each specified degree of freedom, therefore, the risk score is zero when the measured range of motion is within the target range of motion) and
if the joint angle is not within the feasible range for the joint, the joint angle penalty has a value which depends on how far outside the feasible range the joint angle is ([0086-0087]: risk score is the magnitude of differences between the actual ranges of motion and the target ranges of motion in each specified degree of freedom, therefore the risk score will depend on how far outside the feasible range the joint angle is).
Kang further teaches that if the risk score exceeds a threshold score [0013], then the patient can be flagged for care provider review [0087], so that the care provider can intervene in the patient’s recovery [0085].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for determining an unworn state of a sensor yielded by the proposed combination, to provide wherein if the joint angle is within a feasible range for the joint, the joint angle penalty is zero and if the joint angle is not within the feasible range for the joint, the joint angle penalty has a value which depends on how far outside the feasible range the joint angle is, as taught by Kang, because although the risk score in Kang shows how risky the angle may be based on how high it is, Leavitt would instead use this to show how unlikely it is that the wearable device is actually being worn (i.e. the higher risk score in Kang would indicate the risk of injury, while the higher score in Leavitt would indicate how unlikely it is that the user is actually wearing the sensor based on how far outside the joint angle is from the feasible range).
In re claim 12, the proposed combination yields discloses wherein if the relative angle is less than or equal to a threshold relative value (Lucas: [0022]: if the first lateral angle is less than an inward lateral angle associated with the bend angle of the threshold), the relative angle penalty is zero (Lucas: [0022]: threshold is not exceeded if the first lateral angle is less than the inward lateral angle i.e. the relative angle penalty would be 0).
The proposed combination fails to yield wherein if the relative angle penalty is greater than the threshold relative value, the relative angle penalty depends on how much greater the relative angle is than the threshold relative value.
Kang teaches wherein if a relative angle penalty ([0086]: relative angle penalty is a measured range of motion in a different degree of freedom from the joint angle discussed in re claim 11 above) is greater than a threshold relative value, the relative angle penalty depends on how much greater the relative angle is than the threshold relative value ([0086-0087]: relative angle penalty i.e. the risk score is the magnitude of difference of the actual ranges of motion in the specified degree of freedom in the joint corresponding to the target ranges of motion).
For substantially the same reasons as discussed in re claim 11 above, it would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for determining an unworn state of a sensor yielded by the proposed combination, to provide wherein if the joint angle is within a feasible range for the joint, the joint angle penalty is zero and if the joint angle is not within the feasible range for the joint, the joint angle penalty has a value which depends on how far outside the feasible range the joint angle is, as taught by Kang, because the relative angle penalty can be used to determine if the risk score exceeds a certain threshold so that a care provider can provide intervention to the patient.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Leavitt et al. (US 2019/0038225) in view of Lucas et al. (US 2015/0022362) in view of Wang et al. (US 2021/0298612) in view of Heijkants et al. (US 2010/0286950).
In re claim 13, Leavitt discloses wherein the relative angle is a difference in a tilt angle of the first body part and the second body part (fig. 9B: angle 983 is calculated based on a tilt angle of the first body part i.e. angle 982 minus the tilt angle of the second body part i.e. angle 981).
Leavitt fails to disclose
where tilting occurs about an axis perpendicular or substantially perpendicular to the plane in which the joint angle is defined.
Heijkants teaches a method [0001] of measuring a joint angle (fig. 1: alpha) between a first member (1) and a second member (2), where tilting occurs about an axis perpendicular or substantially perpendicular to the plane in which the joint angle is defined (fig. 1: tilting occurs at an axis perpendicular to a plane where a joint angle is defined; [0042]).
Heijkants further teaches that any kind of angle differences in a plane perpendicular to an axis may be measured [0042], and that other angles may be measured in a similar way [0042].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for determining an unworn state of a sensor system taught by Leavitt, to provide where tilting occurs about an axis perpendicular or substantially perpendicular to the plane in which the joint angle is defined, as taught by Heijkants, because any kind of angle differences in a plane perpendicular to an axis may be measured, and because other angles may be measured in a similar way.
In re claim 14, the proposed combination (all mapping directed to Leavitt unless otherwise stated) discloses wherein
the joint angle is defined in an x-z plane (fig. 2A: bending of the joint would be defined in the x-z plane i.e. horizontal and depth of the joint bending as detected by the wearable joint rehabilitation device; [0096]) and
the tilt angle is defined in an x-y plane and is non-zero if the first and second body parts undergo a relative roll about an x-axis (fig. 9B: tilt angle is calculated in an x-y plane and would be non-zero if the first and second body parts rotated around the x-axis during flexion or extension of the first and second body parts).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Vogel et al. (US 2016/0278647) discloses detecting whether a wearable device (abstract) is misaligned (abstract) and wherein the wearable device contains components capable of providing data regarding a proper alignment of the wearable device on a user (abstract).
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUMAISA R BAIG whose telephone number is (571)270-0175. The examiner can normally be reached Mon-Fri: 8am- 5pm.
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/RUMAISA RASHID BAIG/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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